Morphogenesis, Inc. Biomarker Analysis Data from IFx-Hu2.0 in Melanoma Refractory to Anti-PD1-Based Therapies Demonstrates Ability to Overcome Primary Resistance to Checkpoint Inhibitors and Trigger an Innate Immune Response

IFx technology harnesses power of innate immune response leveraging body's natural first line of defense against foreign pathogens

Production of tumor-specific antibodies recognizing hundreds of previously unrecognized melanoma tumor epitopes confirmed activation of a systemic immune response

Data consistent with previously reported IFx-Hu2.0 data in advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC)

Data presented at the Society for Immunotherapy of Cancer (SITC) 38^th Annual Meeting

TAMPA, FL / ACCESSWIRE / November 8, 2023 / Morphogenesis, Inc. ("Morphogenesis"), a privately-held Phase 3 clinical-stage biotechnology company developing novel personalized cancer vaccines and tumor microenvironment modulators utilizing first-in-class bifunctional antibody drug conjugates (ADCs) to overcome primary and acquired resistance to current immunotherapies, today announced positive biomarker analysis data from its first-in-human study evaluating IFx-Hu2.0 for patients with melanoma refractory to anti-PD1-based therapies.

The abstract titled, "Immune priming Ifx-Hu2.0 promotes antibody responses necessary for anti-PD1 responses in PD-1 refractory melanoma patients," was recently presented in a poster at the Society for Immunotherapy of Cancer (SITC) 38^th Annual Meeting.

IFx-Hu2.0 is Morphogenesis' lead personalized cancer vaccine candidate that is designed to naturally harness the power of the innate immune response to overcome primary resistance to checkpoint inhibitors.

"Insufficient tumor immunogenicity, allowing tumors to escape immune recognition and attack, results in primary resistance to checkpoint inhibitors. These data, reported in refractory advanced melanoma, along with our recently reported preliminary Phase 1b results in checkpoint inhibitor resistant advanced MCC and cSCC, supports the applicability of IFx's ability to harness the power of the innate immune response to overcome primary resistance to checkpoint inhibitors across multiple cancer types. Given that up to 80% of cancers exhibit primary resistance and don't respond to CPIs, IFx could address a significant unmet medical need," commented James Bianco, M.D., President and Chief Executive Officer of Morphogenesis.

Ifx-Hu2.0 was injected intralesional up to 3 cutaneous lesions in patients with stage III/IV melanoma refractory to chemotherapy, BRAF/MEK and checkpoint inhibitors. Peripheral blood and tumor specimens were collected before and approximately one month post therapy. All seven patients on trial had specimens available for correlative analyses.

The updated clinical information/data presented for the three patients includes: stable disease that was resected after two years without recurrence at > 3.7 years, partial response (PR) lasting 1.1 years, and PR that was resected but then recurred at 1.5 years.

For more information about the company's ongoing Phase 1b IFx-Hu2.0 study, visit Clinicaltrials.gov and reference Identifier NCT04160065.

About Immune Fx (IFx) Personalized Cancer Vaccines

IFx-Hu2.0 administration involves a simple injection into the patient's tumor of a proprietary gene that encodes for an immunogenic bacterial protein which is expressed on the surface of the tumor cell. Recognizing the bacterial protein as being foreign, the patient's immune system is activated "ingesting" the tumor cell and educating the immune system to all of the patient's tumor's neoantigens resulting in the production of tumor specific antibodies and cytotoxic T cells. The presence of activated T cells overcomes resistance to checkpoint inhibitors allowing checkpoint released activated T cells to seek out and destroy the tumor.

Additionally, Morphogenesis is advancing its CD22 targeted, mRNA vaccine (IFx-Hu3.0), toward IND-enabling studies in 2024 for intravenous or autologous whole cell administration for the treatment of B cell malignancies like diffuse large B-cell lymphoma (DLBCL).

About Morphogenesis, Inc.

Morphogenesis is a Phase 3 clinical-stage biotechnology company developing novel personalized cancer vaccines and tumor microenvironment modulators to overcome primary and acquired resistance to immunotherapies. The company's lead personalized cancer vaccine candidate, IFx-Hu2.0, is designed to overcome primary resistance to checkpoint inhibitors. Morphogenesis is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-Hu2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced Merkel Cell Carcinoma. In addition to its cancer vaccine product candidates, Morphogenesis is using its Delta receptor technology to develop small molecule or bi-functional antibody drug conjugates (ADCs) designed to inhibit the immune suppressing effects of Myeloid Derived Suppressor Cells on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors.

For additional information, please visit www.morphogenesis-inc.com.

Contact:

Jenene Thomas
JTC Team, LLC
morphogenesis@jtcir.com

SOURCE: Morphogenesis Inc.